An interventional study of WoundPilot in Wound Complication, Wound Care and Wound and Injuries, sponsored by University Ghent. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University Ghent · Not applicable, Interventional, and Treatment
This study evaluates whether a digital decision support tool, called WoundPilot, can help primary care nurses make more accurate and consistent decisions when caring for patients with chronic wounds.
In daily practice, treatment decisions for chronic wounds can vary between clinicians, even when they assess the same patient. This variation may lead to delays in appropriate care, inconsistent treatment choices, or unnecessary referrals. WoundPilot was developed to guide clinicians through a structured wound assessment and link this assessment to clear treatment recommendations.
In this study, primary care nurses will assess a series of clinical cases either with or without the support of WoundPilot. Their decisions will be compared with an expert reference standard to determine whether the use of WoundPilot improves the accuracy of decisions and reduces differences between nurses.
The results of this study will help determine whether WoundPilot can support more consistent and evidence-based wound care in clinical practice.
Background Clinical decision-making in chronic wound care shows considerable variability, even when clinicians are presented with similar patient information. This variability may result in delayed or inappropriate treatment, inconsistent use of therapies, or failure to escalate care when clinically indicated.
Structured clinical decision support systems (CDSS) aim to reduce unwarranted variation by guiding clinicians through predefined assessment steps and linking these to management pathways. WoundPilot is an evidence-informed CDSS developed to support structured wound assessment and treatment decision-making in primary care.
Objective The primary objective is to evaluate the effect of WoundPilot on the accuracy and consistency of clinical decision-making in chronic wound care among primary care nurses.
Secondary objectives are to:
Study Design
This study is a randomized parallel vignette study conducted among primary care nurses. Participants are randomly assigned to:
Methods Participants include primary care nurses involved in wound care decision-making in home care or nursing home settings.
In the intervention group, participants receive a short training on WoundPilot and use the tool to assess clinical cases. In the control group, participants assess the same type of cases using their usual reasoning and verbalize their decision-making process.
For each case, participants make decisions regarding wound assessment and treatment planning, including supportive therapy, antimicrobial use, debridement, dressing selection, and referral.
An expert reference standard is established by a panel of wound care experts. Participant decisions are compared to this reference.
Outcomes
The primary outcome is the correctness of treatment decisions compared with the expert reference standard. Secondary outcomes include:
Significance This study evaluates whether a structured clinical decision support system can improve the accuracy and consistency of clinical decision-making in chronic wound care. Findings may inform the role of digital decision support tools in supporting evidence-based practice in primary care.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 40 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.
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Exclusion Criteria:
Participants in this arm assess standardized clinical cases of patients with chronic wounds using WoundPilot, a digital clinical decision support system (CDSS). WoundPilot guides users through a structured, stepwise wound assessment, including evaluation of wound etiology, infection, wound evolution, wound bed characteristics, exudate, and wound edges. Based on the assessment, the system provides structured guidance to support treatment decision-making, including recommendations on supportive therapy, local wound management, and referral. Participants receive a brief training on the use of WoundPilot prior to the assessment and then independently evaluate a set of clinical cases using the tool.
Device: WoundPilot
Participants in this arm assess standardized clinical cases of patients with chronic wounds using their usual clinical reasoning, without the support of a clinical decision support system. Participants independently evaluate each case and make decisions regarding wound assessment and treatment planning, including supportive therapy, local wound management, and referral. They are asked to verbalize their reasoning during the assessment process, which is recorded for subsequent analysis. No additional training or decision support tool is provided.
WoundPilot is a software-based clinical decision support system (CDSS) designed to support structured wound assessment and treatment decision-making in primary care. The system guides users through a stepwise assessment process using predefined decision nodes, including evaluation of wound etiology, infection, wound evolution, wound bed characteristics, exudate, and wound edges. Based on the entered information, WoundPilot provides structured guidance to support treatment planning, including recommendations on supportive therapy, local wound management, and referral. The system incorporates evidence-informed clinical pathways and aims to standardize wound assessment and reduce variability in clinical decision-making.
Accuracy of Treatment Decisions Compared With an Expert Reference Standard
Accuracy of treatment decisions will be assessed by comparing each participant's treatment decisions for standardized chronic wound cases with an expert reference standard. Treatment decisions include supportive therapy, antimicrobial therapy, wound cleansing, debridement, choice of wound product, management of wound edges or wound environment, protection of exposed bone or tendon when applicable, referral or contact with another healthcare professional or department, wound swab, and additional technical investigations. Accuracy will be analyzed at the level of individual treatment decision components and as a composite correctness score per case.
Time frame: During a single assessment session (approximately 2 hours)
Alignment of Wound Assessment Decisions With Expert Reference Standard
Accuracy of wound assessment decisions will be evaluated by comparing participant assessments with an expert reference standard. This includes classification of wound type, assessment of infection (local, spreading, or systemic), evaluation of wound evolution, wound bed characteristics, presence of hypergranulation or exposed structures, amount of exudate, and assessment of wound edges and surrounding skin.
Time frame: During a single assessment session (approximately 2 hours)
Between-Nurse Variability in Treatment Decisions
Variability in treatment decisions between participants will be assessed within each study group. Agreement between participants will be quantified using statistical measures such as Fleiss' kappa to evaluate consistency of treatment decisions across standardized cases.
Time frame: During a single assessment session (approximately 2 hours)
Between-Nurse Variability in Wound Assessment Decisions
Variability in wound assessment decisions between participants will be evaluated within each study group. Agreement will be quantified using appropriate statistical methods (e.g., Fleiss' kappa) to assess consistency in the evaluation of decision-critical wound parameters.
Time frame: During a single assessment session (approximately 2 hours)
Recognition and Interpretation of Clinical Change
Participants' ability to recognize and correctly interpret clinical changes over time will be assessed by comparing decisions between initial and follow-up case scenarios. Correct identification of wound evolution and appropriate adaptation of treatment decisions will be evaluated against the expert reference standard.
Time frame: During a single assessment session (approximately 2 hours)
Usability of WoundPilot (Dutch System Usability Scale)
Usability of WoundPilot will be assessed using the Dutch System Usability Scale (D-SUS), a validated 10-item questionnaire scored on a 5-point Likert scale. The D-SUS provides a total score ranging from 0 to 100, with higher scores indicating better usability.
Time frame: During a single assessment session (approximately 2 hours)
Plan to share: No — Individual participant data (IPD) will not be shared due to the small sample size and the risk of potential re-identification of participants, as well as the inclusion of qualitative data (e.g., verbalized reasoning) that may contain indirectly identifiable information.
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